Surgical stapler

ABSTRACT

An anvil assembly comprising an anvil shaft and an anvil head, the anvil head having anvil depressions for forming surgical staples. The anvil head is mounted to the anvil shaft and the anvil shaft has a longitudinal axis and first and second spaced apart elongated projections attached to the anvil shaft and extending therefrom. The projections are configured and dimensioned to retain a purse string suture.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/637,841, filed Dec. 15, 2009, which claims the benefit of, andpriority to, U.S. Provisional Patent Application Ser. No. 61/142,660,filed Jan. 6, 2009, now expired, the entire content of each of theabove-identified applications being incorporated in their entireties byreference herein.

BACKGROUND

1. Technical Field

The present disclosure relates to a surgical stapling device and moreparticularly to a surgical stapling device suitable for treatment ofinternal hemorrhoids.

2. Background of Related Art

Anastomosis is the surgical joining of separate hollow organ sections.In known circular anastomosis procedures, two ends of organ sections arejoined by means of a stapling device which drives a circular array ofstaples through each organ section and simultaneously cores any tissueinterior of the driven circular array of staples to free a tubularpassage. Examples of such devices are described in U.S. Pat. Nos.7,234,624, 6,945,444, 6,053,390, 5,588,579, 5,119,983, 4,646,745,4,576,167, 4,473,077.

Typically the circular stapling device has an elongated shaft having ahandle portion at a proximal end and a staple cartridge at a distal end.An anvil assembly including an anvil rod with an attached anvil head ismounted to the distal end of the device. The anvil is approximated toclamp tissue between the staple holding component and the anvil. Theclamped tissue is stapled by actuation of the handle portion to drivecircular arrays of staples through the tissue and into anvil depressionson the anvil head to form the staples. An annular knife is advanced withthe handle actuation to core tissue inboard of the staple array.

Surgical stapling devices for performing circular anastomosis have alsobeen used to treat hemorrhoids in the rectum. Hemorrhoids are masses oftissue in the anus containing enlarged blood vessels. Internalhemorrhoids are inside the anal canal; external hemorrhoids lie outsidethe anal canal. Hemorrhoidectomy is a surgical procedure in which thehemorrhoids are removed. Stapled hemorrhoidopexy is a surgical procedurein which a stapling device is used to remove tissue just above thehemorrhoids in order to pull the hemorrhoids back up inside the rectumand reduce the symptoms. The staples interrupt the blood flow of thesuperior hemorrhoidal arterial branches, cutting off the blood supply,thus causing the hemorrhoids to shrink. This is used for treatment ofinternal hemorrhoids.

During the use of a circular stapling device for hemorrhoid treatment,the anvil head and the staple holding component of the device areinserted through and into the rectum with the anvil head and thestapling holding component in an open or unapproximated position.Thereafter, a purse string suture is used to pull the internalhemorrhoidal tissue and/or mucosal tissue toward the anvil rod. Next,the anvil head and the staple holding component are approximated toclamp the hemorrhoidal tissue and/or mucosal tissue between the anvilhead and the staple holding component. The stapling device is fired toremove the hemorrhoidal tissue and/or mucosal tissue and staple the cuttissue.

It would be advantageous to provide a device with an option to adjustthe amount of tissue for purse stringing to enhance control over theamount of tissue removed.

SUMMARY

The present disclosure provides an anvil assembly comprising an anvilshaft and an anvil bead. The anvil head has anvil depressions forforming surgical staples and is mounted to the anvil shaft. The anvilshaft has a longitudinal axis and first and second spaced apartelongated projections attached to the anvil shaft and extendingtherefrom, the projections configured and dimensioned to retain a pursestring suture.

In a preferred embodiment, the projections are positioned at an acuteangle with respect to the longitudinal axis of the anvil shall,preferably angling away from the anvil head toward a proximal end of theanvil shall. In one embodiment, the plurality of projections aresubstantially equidistantly axially spaced. In one embodiment, theprojections comprise a plurality of elongated pins.

In another aspect, the present disclosure provides an anvil assemblycomprising an anvil shaft and an anvil head, the anvil head having anvildepressions for forming surgical staples. The anvil head is mounted tothe anvil shaft. The anvil shaft has a longitudinal axis and first andsecond spaced apart cutouts formed therein, the cutouts progressivelynarrowing in width in a direction toward an opposite wall of the anvilshaft and configured and dimensioned to cinch a purse siring suturepositioned therein.

In one embodiment, the cutouts are substantially equidistantly spaced.Preferably, the cutouts curve inwardly and are directed toward a distalend of the anvil shaft such that they form projecting regions anglingtoward a proximal end of the anvil shaft.

The present disclosure also provides in another aspect a surgicalstapler comprising a handle assembly, an elongated body portionextending distally from the handle assembly, and a head portion disposedadjacent a distal end of the elongated body portion and including ananvil assembly and a shell assembly. The anvil assembly is movable inrelation to the shell assembly between spaced and approximated positionsand has an anvil head and a plurality of elongated projections forreceiving a purse string suture. The projections extend at an angle withrespect to a longitudinal axis of the anvil shaft such that longitudinalaxis of the projections are angled with respect to the longitudinal axisof the anvil shaft.

In one embodiment, the anvil assembly includes an anvil shaft extendingproximally of the anvil head and removably mountable to an anvilretainer of the stapler. In one embodiment, the projections are integralwith the anvil shaft and formed by angled cuts in the anvil shaft, thecuts preferably angling toward a distal end of the anvil shaft. In oneembodiment, the cuts have a first dimension and a second dimensioncloser to a center of the anvil shaft smaller than the first dimension.In this embodiment, the dimension of the cuts can progressively decreasetoward the longitudinal axis of the shaft to form cinch regions for thesuture. In other embodiments, the projections are attached to the anvilshaft and comprise a plurality of pins substantially equidistantlylongitudinally spaced.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described hereinbelowwith reference to the drawings, wherein:

FIG. 1 is a perspective view of a first embodiment of the surgicalstapler of the present disclosure;

FIG. 1A is a longitudinal cross-sectional view of the surgical staplerof FIG. 1;

FIG. 1B is a cross-sectional view of the anvil retainer of the staplerof FIG. 1;

FIG. 1C is a side view of the connector of the stapler of FIG. 1;

FIGS. 1D and 1E are cross-sectional views of portions of the shellassembly of FIG. 1;

FIGS. 2 and 3 are close up perspective and side views, respectively, ofthe anvil assembly and shell assembly of FIG. 1;

FIG. 3A is a cross-sectional view of an alternate embodiment of theanvil head;

FIG. 4 is a side view of an alternate embodiment of the anvil assemblyfor use with the surgical stapler of FIG. 1;

FIG. 5 is a top view of a portion of the anvil shaft of FIG. 4;

FIG. 6 is an exploded view of an alternate embodiment of the anvilassembly of the present disclosure;

FIG. 7 is a perspective view of the anvil assembly of FIG. 6;

FIG. 8 is a perspective view of an alternate embodiment of the anvilassembly of the present disclosure;

FIG. 9 is a side view illustrating placement of the purse string suturein an anvil assembly of the present disclosure; and

FIG. 10 is a side view illustrating placement of the purse string suturein an anvil assembly of the present disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

The presently disclosed surgical stapler will now be described in detailwith reference to the drawings in which like reference numeralsdesignate identical or corresponding elements in each of the severalviews. Throughout this description, the term “proximal” will refer tothe portion of the stapler closer to the operator and the term “distal”will refer to the portion of the instrument further from the operator.The presently disclosed stapler is particularly suited for surgicalprocedures for the treatment of colon prolapse and hemorrhoids, althoughit can be used for other procedures.

FIGS. 1 and 1A illustrate one embodiment of the presently disclosedhemorrhoid stapler 10. Briefly, surgical stapler 10 includes a handleassembly 12, a central body or elongated portion 14 and a distal headportion 15. Head portion 15 includes an anvil assembly 18 and a shellassembly 20. Except where otherwise noted, the components of stapler 10are generally formed from thermoplastics including polycarbonates, andmetals including stainless steel and aluminum. The particular materialselected to form a particular component will depend upon the strengthrequirements of the particular component. For example, the anvil may beformed from a metal such as stainless steel, whereas portions of handleassembly 12 may be formed from thermoplastic such as a polycarbonate.Alternately, other materials having the requisite strength requirementswhich are suitable for surgical use may be used to form the componentsof stapler 10.

Handle assembly 12 includes a stationary handle 22, a firing trigger 24,an approximation knob 26, an indicator assembly 28, and a lockoutmechanism 30. Approximation knob 26 functions to retract and advance adrive screw 32 to advance or retract anvil assembly 18 in relation toshell assembly 20. Firing trigger 24 functions to advance a pusher link34 to actuate a pusher to eject staples from shell assembly 20. Each ofthe components of handle assembly 12 identified above are substantiallyas described in U.S. Pat. No. 7,303,106 (“'106 patent”) entitled“Surgical Stapling Device With Visual Indicator” which issued on Dec. 4,2007. The '106 patent is incorporated herein by reference in itsentirety. Accordingly, these components and assemblies will not bedescribed in detail herein.

Referring to FIGS. 1A-1C, an anvil retainer 36 is secured to a distalend of drive screw 32 by a connector 38. Anvil retainer 36 includes abody 40 defining an elongated bore 42. A proximal end 40 a of body 40includes a longitudinal slot 44 and a pair of transverse throughbores46. A distal end 40 b of body 40 includes three segmented flexible arms48. Each of the arms 48 has an inner retention surface 50 which will bedescribed in further detail below.

Connector 38 includes a central body 52 having a proximal extension 54and a distal extension 56. Proximal extension 54 is dimensioned to bereceived within a slot (not shown) formed in the distal end of drivescrew 32. Extension 54 and the distal end of drive screw 32 each definea transverse throughbore for receiving a pin, rivet, screw or the like39A for fixedly securing connector 38 to drive screw 32. Distalextension 56 is dimensioned to be received within slot 44 of body 40 ofanvil retainer 36. Extension 56 includes a pair of spaced throughboreswhich align with throughbores 46 of anvil retainer 36 and aredimensioned to receive pins, screws, rivets or the like 39B to fixedlysecure anvil retainer 36 to connector 38. Although pins, screws, rivetsor the like are specifically disclosed for securing connector 38 todrive screw 32 and anvil retainer 36, other known fastening techniquesare envisioned, e.g., welding, crimping, and interlocking structure. Inan alternate embodiment, the connector and anvil retainer can bereplaced with a single part, e.g. an elongated anvil retainer, having anextended length to function similarly to the extended length resultingfrom the provision of connector 38.

Referring to FIGS. 2 and 3, anvil assembly 18 includes an anvil shaft orcenter rod 64 and an anvil head 66. Anvil shaft 64 includes a taperedproximal blunt end 64 a (FIG. 1A) and an opposite distal end formounting to anvil post 68 of anvil head 66. A pin 72 (or alternatively ascrew, rivet or the like) mounts the anvil post 68 to anvil shaft 64. Itshould be appreciated, that anvil post 68 can be pivotally mounted toanvil shaft 64 so that the anvil can move between an operativenon-tilted position to a tilted position. This is described in detail inU.S. Pat. No. 7,303,106, the entire contents of which are incorporatedherein by reference. Alternatively, the anvil can be fixedly(non-pivotably) mounted to the anvil shaft 64. This is shown for examplein the embodiment of FIGS. 6 and 7 described below.

Anvil shaft 64 includes a stepped surface or ring 74 which is configuredto engage retention surfaces 50 (FIG. 1B) of flexible arms 48 toreleasably secure anvil shaft 64 to anvil retainer 36. An orientationgroove or grooves is provided in anvil shall 64 beneath splines 76 toeffect proper alignment of splines 76 about shaft 64 to facilitateproper alignment of anvil assembly 18 and shell assembly 20 when anvilassembly 18 is retracted (approximated) towards shell assembly 26.

Anvil shaft 64 can have over-molded splines 76, or alternatively, theanvil shaft can have machined splines.

Anvil shaft 64 has a series of longitudinally spaced projections in theform of pins 78 as shown. The pins 78 provide for a purse-stringattachment location. Although the projections are shown in the form ofpins, other outwardly extending elongated structure for retaining pursestring suture is also contemplated. As shown, five pins are provided,although a fewer or greater number of pins are also contemplated.

The pins 78 extend radially outwardly from the anvil shaft 64 and arepositioned at an angle to a longitudinal axis of the anvil shaft. Thatis, a longitudinal axis of the pins is angled with respect to alongitudinal axis of the anvil shaft 64. In a preferred embodiment, theangle of the pins with respect to the longitudinal axis is between about30 degrees and about 60 degrees, although other angles are alsocontemplated as long as they are sufficient to capture the suture. Thepins 78 preferably angle toward the proximal end of the anvil shall 64to help retain the suture therebetween, but can alternatively be angledin other directions. Also, although shown as straight, the projectionscan be curved and/or have multiple angles. The pins can be pressed,machined or attached by other techniques to the anvil shaft 64. Theprojections, e.g. pins, can be formed integrally/monolithically with theanvil shaft or separate components attached to the shaft.

The pins are configured to receive a purse-string suture therebetween,thereby creating a catch or capturing region to retain the suturebetween two adjacent pins 78. The series of pins 78 enables the user todecide the amount of tissue desired for purse stringing, e.g. placingthe suture between the two proximal pins 78 a, 78 b would enableadditional tissue to be taken and presented for stapling compared todistal pins.

It should be appreciated that the suture can also be retained bywrapping around the individual pin or pins 78 instead of placementbetween two adjacent pins.

Although the pins are shown as substantially identical, the size andconfiguration of the pins can vary along the length of the anvil shaft64. Also, although shown substantially equidistantly axially spaced, thedistance between adjacent pins can vary.

In the illustrated embodiment, the anvil shaft is of circularcross-section with the pins extending radially from the circumferentialsurface of the anvil shaft.

In the alternate embodiment of FIGS. 4 and 5, a different structure isdisclosed for capturing and retaining the purse string suture. Exceptfor the suture retaining structure, the anvil assembly and shellassembly are identical to that described with respect to the embodimentof FIG. 1. The anvil shaft 164 is mown table to the surgical staplersdisclosed herein. For brevity, the description of these identicalcomponents will not be repeated.

Turning to the structure for receiving the purse string suture of FIGS.4 and 5, the anvil shaft 164 has a series of cutouts 178 forming cinchspots to grasp the suture. As shown, each of the cutouts 178 is arcuateand cut in a direction toward a distal end 165 of the anvil shaft 164.This angled cut forms a plurality of projecting surfaces or projectionsextending toward a proximal end 167 of the anvil shaft 164. The cutouts178 narrow in dimension as they extend toward an opposing wall of theshaft, such that inner region 180 is narrower than outer region 181. Theinner regions 180 preferably narrow to a dimension smaller than an outerdimension of the purse string suture so the suture is cinched within theinner region 180 when placed through the cutout 178. As with the pins 78described above, the user can select the amount of tissue desired byselecting the appropriate cutout 178 in which to cinch the suture, e.g.the more proximal the cutout, the more tissue to be taken and presentedfor stapling (the proximalmost cutouts 178 a providing the most tissue).Although five cutouts are shown, a fewer or greater number of cutoutsare also contemplated. The cutouts are also shown as extending to adepth approximately up to the central longitudinal axis of the shaft;cutouts of different depths are also contemplated. Also, although thecutouts as shown are substantially identical, the configuration of thecutouts can vary along the anvil shaft 164. Also, although shownequidistantly axially spaced, the spacing between the cutouts 178 can bevaried. The remaining components, e.g. anvil head, are identical to theembodiment of FIG. 1.

As discussed above, anvil retainer 36 (FIG. 1B) defines an elongatedbore 42 which is dimensioned to receive anvil shaft 64 such that steppedsurface 74 of shaft 64 engages retention surface 50 to releasably secureanvil assembly 18 to anvil retainer 36. In one embodiment, anvil shaft64 is of a length to protrude from the anus when properly positionedduring a surgical procedure to treat colon prolapse. By protruding fromthe anus, the interface between the anvil shaft 64 and anvil retainer 36is exposed and visible for attachment. For example, in one embodiment,shaft 64 extends outwardly from a face 86 (FIG. 2) of anvil head 66 adistance greater than about three inches, and for example extendsoutwardly from face 86 of anvil head 66 a distance of about 3.55 inches.In another embodiment, the shaft extends outwardly a distance of greaterthan about live inches, and for example extends about 5.234 inches.

Anvil head 66 is shown with a low distal profile, however, other shapesare contemplated such as the bulbous, smoothly contoured anvil 266illustrated in FIG. 3A. Bulbous portion 296 facilitates insertion ofhead 266 through a purse string suture. The anvil head 266 can beattached to the anvil shafts disclosed herein. Cutting ring 292 is shownattached to anvil head 266.

The bulbous anvil head can be used with anvils pivotally attached to ananvil shaft via anvil post 270. Alternatively, the bulbous anvil headcan be non-pivotably attached to the anvil shaft such as anvil head 366,466, shown in FIGS. 7 and 8, respectively. In the embodiment of FIGS. 6and 7, bulbous anvil head 366 has an anvil post 368 which receivesproximal end 365 of anvil shaft or center rod 364 thereover. A pin 372(or other fastening or attachment structure) extends though opening 367and 369 of anvil shaft 364 and anvil post 368, respectively, to fixedly(non-pivotably) secure the anvil shaft 364 to anvil head assembly 366.Anvil 373 containing annular rows of anvil depressions is secured toanvil head 366. Cutting ring 375 is positioned in a recess of anvil 373.In all other respects, the anvil assembly 318 is identical to the anvilassembly of FIG. 1 and has, e.g. angled projections 378 for reception ofpurse string sutures, splines 376, etc. A marking ring 380 adjacent theproximalmost suture receiving structure can also be provided as shown inthe embodiment of FIG. 6, as well as in the other embodiments disclosedherein, to indicate to the user that a proximalmost pin or cutout isbeing utilized which present the largest amount of tissue for stapling.

A bulbous anvil head can also be used in a non-pivoting anvil assemblysuch as illustrated in FIG. 8. The anvil assembly 418 of FIG. 8 isidentical to the anvil assembly 165 of FIG. 4, except that the anvilhead is non-pivotally attached to anvil shaft 464, a bulbous head 466 isprovided, and a marking ring 480 is provided on anvil shaft 464 adjacentthe proximalmost cutout 478 a of the series of cutouts 478 formingprojections.

It should be appreciated that the anvil heads of the embodiments ofFIGS. 1 and 4, respectively, can be used with anvil assemblies whereinthe anvil heads non-pivotably mounted to the anvil shafts, such as theembodiments of FIGS. 7 and 8.

Referring to FIGS. 1A, 1D and 1E, shell assembly 20 is secured to thedistal end of central body portion 14 in a manner substantially similarto that described in the '106 patent incorporated herein by reference.Shell assembly 20 includes a shell or housing 98, a pusher back 100, acylindrical knife 102, and a staple guide housing one or more rows ofstaples (not shown). Vent holes 29 (FIG. 1) are provided in shellassembly 20.

Shell 98 includes an outer housing portion 106 and an inner guideportion 108 having grooves 110 for mating with splines 76 on anvil shaft64. Outer housing portion 106 defines a throughbore 112 having a distalcylindrical section 114, a central conical section 116 and a proximalsmaller diameter cylindrical section 118. A plurality of openings 120are formed in conical section 116. Openings 116 are dimensioned topermit fluid and tissue passage during operation of stapler 10. A pairof diametrically opposed flexible engagement members 122 are formed onproximal cylindrical section 118 of shell 98. Engagement members 122 arepositioned to be received in openings formed on a distal end of bodyportion 14 to secure shell 98 to body portion 14.

Pusher back 100 includes a central throughbore 124 which is slidablypositioned about inner guide portion 108 of shell 98. Pusher back 100includes a distal cylindrical section 126 which is slidably positionedwithin distal cylindrical section 114 of shell 98, a central conicalsection 128 and a proximal smaller diameter cylindrical section 130. Theproximal end of pusher back 100 includes members 132 which areconfigured to lockingly engage with a pusher link of stapler 10 asdescribed in the '106 patent incorporated by reference herein. Pusherback 100 also defines a receptacle 133 for receiving excised tissue.Receptacle 133 is preferably configured to have a depth of substantiallywithin the range of approximately 0.275 cm (approximately 0.75 inches)to approximately 0.70 cm (approximately 2.0 inches). For example, in oneembodiment, the receptacle 215 is configured to define a depth ofapproximately 0.52 cm (approximately 1.33 inches)

The distal end of pusher back 100 includes a pusher 134. Pusher 134includes a multiplicity of distally extending fingers 136 dimensioned tobe slidably received within slots (not shown) formed in staple guide 104to eject staples (not shown) therefrom. Cylindrical knife 102 isretained within the central throughbore of pusher back 100 to fixedlysecure knife 102 in relation to pusher 134. Knife 102 may be retainedwithin pusher back 100 using adhesives, crimping, pins, friction, etc.The distal end of knife 102 includes a circular cutting edge.

The rigid bushing 140 is supported in the proximal end of inner guideportion 108 of shell 98. Bushing 140 defines a throughbore dimensionedto slidably receive anvil retainer 36 and anvil shaft 64 of anvilassembly 18. Bushing 140 provides lateral support for flexible arms 48of anvil retainer 36 when the anvil assembly 18 has been approximated toprevent disengagement of anvil assembly 18 from anvil retainer 36. Inthe unapproximated position, flexible arms 48 are positioned externallyof bushing 140 to permit flexing of the arms for removal of anvilassembly 18 from retainer 36.

As discussed above, stapler 10 is particularly suitable for use insurgical procedures for treating colon prolapse. During such procedure,an access port can be inserted into the anus to facilitate access to theprolapsed colon. Next, a purse string suture S1 is placed into, above orin the vicinity of the colon prolapse and the anvil assembly 318 isinserted through the access port into the anus and rectum. Thereafter,the purse string suture S1 is placed between (or alternately wrappedaround) selected adjacent pins 378 (or pins 78) as shown in FIG. 9. Pins378 are longitudinally spaced along shaft 364 such that the amount oftissue drawn into the shell assembly can be controlled by properlyselecting the two pins 378 (or 78) to which the purse string suture isinserted between. A greater amount of tissue will be drawn into shellassembly by capturing and retaining the purse siring suture between thetwo proximalmost pins 378 a, 378 b, The suture ends are tightened andpulled toward the user, therefore pulling the tissue proximally. Thesurgeon can then visualize the tissue to be stapled, i.e. the tissuedonut to be removed. The stapling instrument, e.g. instrument 10 of FIG.1, is inserted through the port and attached to the anvil assembly, withthe elongated anvil shaft and elongated instrument shaft providingincreased visibility. Anvil assembly 318 and the shell assembly 20 arethen approximated via knob 26 to draw the prolapsed colon into shellassembly 20.

When surgical stapler 10 is fully approximated, firing trigger 24 can beactuated or fired in a manner described in the '106 patent to staple,sever and allow removal of a portion of the prolapsed colon. Thereafter,the stapler is at least partially unapproximated and removed from theanus with the excised tissue contained within receptacle 133 of pusherback 100 within shell assembly 20. In the embodiments where a tiltinganvil is used, after the firing step and sufficient movement of theanvil away from the shell assembly 20, the anvil will tilt (not shown)to its inoperative position to facilitate-removal.

FIG. 10 illustrates a purse string suture S1 placed within a cutout 478of anvil shaft 474 of anvil assembly 418 of FIG. 8. FIG. 10 alsoillustrates the shell assembly 20 containing the staples with theprocedural steps similar to that described above with reference to FIG.9.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplifications ofpreferred embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1-17. (canceled)
 18. A method of performing a surgical procedurecomprising: securing a suture to a section of target tissue of apatient; inserting an anvil assembly of a surgical staple applyingapparatus into the patient; selecting an amount of the target tissue tobe resected by securing the suture to one of a series of cutouts formedin an anvil shaft of the anvil assembly; connecting the anvil assemblyto a body of the surgical staple applying apparatus; approximating theanvil assembly and a shell assembly of the surgical staple applyingapparatus; and firing the surgical staple applying apparatus.
 19. Themethod of claim 18, wherein approximating the anvil assembly and theshell assembly includes drawing the target tissue into the body of thesurgical staple applying apparatus.
 20. The method of claim 19, whereinfiring the surgical staple applying apparatus includes advancing a knifemember to sever the target tissue.